MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE DISSECTOR; DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	GPD1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a mitral valve repair/replacement via median sternotomy with concomitant pulmonary vein isolation using a gpd1.The gpd1 was used to dissect around the left pulmonary veins.Shortly after using the emt1 to ablate the left pulmonary veins, a small tear was identified at the junction of the left superior pulmonary vein and the posterior wall of the left atrium.The tear was repaired with prolene sutures.The left atrial appendage was excised, and the opening was used to close the tear.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
The device was not returned for evaluation however, a device history review was conducted and there is nothing in the product history record that would indicate that the devices were released with any non-conformances that would contribute to the subject complaint.

• Brand Name: ATRICURE DISSECTOR
• Common Device Name: DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 21061527
• Report Number: 3011706110-2025-00002
• Device Sequence Number: 8153223
• Product Code: GDI
• UDI-Device Identifier: 10840143902130
• UDI-Public: (01)10840143902130(17)270701(10)144214
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: GPD1
• Device Catalogue Number: A000418
• Device Lot Number: 144214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMT1.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male
• Patient Weight: 147 KG